Strensiq

RSS

asfotase alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

Strensiq is a medicine used long-term to treat patients with hypophosphatasia that started in childhood. Hypophosphatasia is a rare inherited disease of the bones which can lead to early loss of teeth, malformed bones, frequent bone fractures, and difficulty breathing.

Strensiq contains the active substance asfotase alfa.

Hypophosphatasia is rare, and Strensiq was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 3 December 2008.

This EPAR was last updated on 08/10/2018

Authorisation details

Product details
Name
Strensiq
Agency product number
EMEA/H/C/003794
Active substance
asfotase alfa
International non-proprietary name (INN) or common name
asfotase alfa
Therapeutic area (MeSH)
Hypophosphatasia
Anatomical therapeutic chemical (ATC) code
A16AB
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Alexion Europe SAS
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
28/08/2015
Contact address
1-15 avenue Edouard Belin
92500 Rueil Malmaison
France

Product information

13/09/2018 Strensiq - EMEA/H/C/003794 - II/0029

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

Therapeutic indication

Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.

Assessment history

Changes since initial authorisation of medicine

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